MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 09/01/2023

Event Type  Death  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f19 captures the surgical intervention performed to address the perforation.Imdrf impact code f02 captures the reportable event of death.

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the transverse colon during a stent placement procedure performed on an unknown date.The patient's anatomy was tortuous.During the procedure, the patient had perforation.Subsequently, the patient underwent surgery to address the perforation; however, on an unknown date, post surgery, the patient passed away.The patient's cause of death is unknown; however, it was confirmed that the patient had many comorbidities and health problems prior to stent placement.In addition, the patient had an enlarged colon considerably increasing the risk of perforation.Furthermore, there were no problems reported on the wallflex enteral stent, however, the patient's anatomy was very difficult.

• Brand Name: WALLFLEX COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17923304
• MDR Text Key: 325522712
• Report Number: 3005099803-2023-05444
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death